Trials / Completed
CompletedNCT04935879
A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.
Detailed description
Eligible participants will be administered inclacumab or placebo intravenous (IV) every 12 weeks. The total duration of treatment for each participant will be 48 weeks. Participants that complete the study through Week 48 will be provided the opportunity to enroll in an open-label extension (OLE) study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inclacumab | Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion. |
| DRUG | Placebo | Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug |
Timeline
- Start date
- 2021-10-04
- Primary completion
- 2024-06-06
- Completion
- 2024-06-06
- First posted
- 2021-06-23
- Last updated
- 2025-12-02
- Results posted
- 2025-12-02
Locations
58 sites across 12 countries: United States, Brazil, Colombia, Egypt, France, Kenya, Lebanon, Nigeria, Oman, Saudi Arabia, Tanzania, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04935879. Inclusion in this directory is not an endorsement.